FEDERAL FOOD, DRUG, AND COSMETIC ACT

Bills and resolutions

Business and industry: prohibit use of patents, trade secrets, or other intellectual property to inhibit competition (see S. 4918), S4969 [22SE]

DEA: modify registration requirements relative to research with controlled substances (see S. 5123), S6779 [17NO]

Dept. of HHS: clarify conditions to approve generic drug applications with labeling temporarily different than brand name drug (see S. 4351), S2785 [6JN] (see H.R. 6973), H1372 [8MR]

——— contract with third-party organizations to carry out independent value assessments for approved drugs (see H.R. 9321), H8541 [16NO]

——— grant eligible researchers access to drugs or biologic products at discounted price for qualified research (see S. 4026), S2091 (see S. 4053), S2092 [7AP] (see H.R. 7472), H4432 [7AP]

——— improve inspections of foreign drug manufacturing establishments (see H.R. 7006), H1421 [9MR]

——— require drug manufacturers to include printed inserts containing drug information when they ship their products to pharmacies (see H.R. 6519), H307 [28JA]

Diseases and disorders: prohibit Federal Government from limiting State access to key therapies and from prioritizing Federal contracts over State contracts relative to purchasing supplies to combat coronavirus pandemic (see S. 3440), S23 [4JA] (see H.R. 6832), H1145 [25FE]

——— prohibit vaccination mandates for coronavirus (see H.R. 6395), H193 [13JA]

Drugs: improve patient access to emerging medication therapies by clarifying scope of permitted communications between biopharmaceutical manufacturers and population health decision makers (see H.R. 7008), H1421 [9MR] (see H.R. 9297), H8507 [15NO]

——— mitigate effects of coronavirus pandemic on incentives for development of orphan drugs (see H.R. 8641), H7544 [2AU]

——— reauthorize provision relative to drugs containing single enantinomers (see S. 4378), S2910 [13JN]

FDA: accelerate approval of products for serious or life-threatening diseases or conditions (see H.R. 6996), H1373 [8MR]

——— act upon pending submissions for new infant formula and increase regulatory flexibility in event of infant formula shortage (see H.R. 8010), H5445 [9JN]

——— allow digital communication of prescribing information for drugs, including biological products (see H.R. 7559), H4453 [21AP]

——— allow for alternatives to animal testing for purposes of drug and biological product applications (see S. 5002), S5540 [29SE]

——— allow waivers of annual medical device establishment registration fees for small businesses (see S. 4385), S2910 [13JN] (see H.R. 9329), H8587 [17NO]

——— amend process informing persons submitting abbreviated application for new drug whether new drug is qualitatively or quantitatively same as listed drug (see H.R. 7032), H1422 [9MR]

——— authorize program to support adoption of, and improve development of, innovative approaches to pharmaceutical product design and manufacturing (see H.R. 6988), H1373 [8MR]

——— clarify reporting requirements for establishments within foreign country engaged in manufacture, preparation, propagation, compounding, or processing of active pharmaceutical ingredients (see H.R. 6483), H300 [25JA]

——— clarify requirements for remanufacturing of medical devices (see H.R. 7253), H3895 [28MR]

——— classify human donor milk that undergoes pasteurization as exempt infant formula (see H.R. 7358), H4126 [1AP]

——— ensure safety of imported seafood (see H.R. 8732), H7716 [19AU]

——— establish additional authorities regarding conduct of pediatric investigations of molecularly targeted drugs to treat cancer (see S. 4215), S2493 [12MY] (see H.R. 6972), H1372 [8MR]

——— establish process to allow holders of abbreviated new generic drug applications to make labeling changes to include new or updated safety-related information (see H.R. 9011), H8220 [28SE]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 6513), H307 [28JA]

——— expand certain authorities relative to recall of controlled substances to apply with respect to all drugs (see H.R. 6545), H330 [1FE]

——— improve infant formula supply chain (see H.R. 7830), H5174 [18MY]

——— improve safety and supply of infant formula (see H.R. 7933), H5232 [3JN]

——— make certain changes relative to approval of abbreviated applications for approval of new animal drugs (see H.R. 8857), H7881 [15SE]

——— make food and food additives that are sterilized using ethylene oxide or propylene oxide misbranded unless that process is disclosed on labeling (see H.R. 7167), H3853 [18MR]

——— modernize methods of authenticating controlled substances in pharmaceutical distribution supply chain (see H.R. 7653), H4713 [3MY]

——— modernize therapeutic equivalence rating determinations (see H.R. 7377), H4152 [4AP]

——— notify public about new information relative to medical device in order to reduce or limit number of patients exposed to potential risk identified based on such emerging signal (see S. 4349), S2785 [6JN] (see H.R. 7646), H4713 [3MY]

——— prevent food shortages, including shortages of infant formula and certain medical foods (see S. 4256), S2586 [18MY] (see H.R. 7989), H5409 [8JN]

——— prohibit alteration, falsification, fabrication, destruction, omission, or removal of records or certain information required to be produced or maintained for drugs (see H.R. 6431), H252 [19JA]

——— provide process to lock and suspend domain names used to facilitate online sale of drugs illegally (see S. 3984), S1910 [31MR]

——— publicly release summary of reasoning for approving drugs, biological products, and other therapies via accelerated approval process (see S. 4390), S2939 [14JN]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (see H. Res. 1434), H8395 [14OC]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (H. Res. 1434), adopt (see H. Res. 1529), H9982 [21DE]

——— reauthorize Critical Path Public-Private Partnerships (see S. 4152), S2358 [5MY] (see H.R. 7658), H4713 [3MY]

——— reauthorize Pediatric Device Consortia (PDC) grant program and allow profits for certain Humanitarian Device Exemption (HDE) devices (see H.R. 7679), H4721 [6MY]

——— require manufacturers of dietary supplements to list dietary supplements (see S. 4090), S2154 [26AP]

——— require manufacturers to report medical device shortages, expedite review of essential medical devices, and grant authority to request information relative to security of U.S. medical product supply chain (see H.R. 7208), H3862 [24MR]

——— require premarket submission of cyber devices to include information demonstrating reasonable assurance of safety and effectiveness throughout life cycle of cyber device (see S. 3983), S1910 [31MR] (see H.R. 7084), H3742 [15MR]

——— require prompt reports on marketing status by holders of approved applications for biological products (see S. 4302), S2708 [25MY] (see H.R. 7035), H1422 [9MR]

——— require recall of electronic nicotine delivery systems that have not been subject to premarket review (see H.R. 8202), H5877 [23JN]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (see S. 4348), S2752 [26MY] (see S. 4535), S3308 [14JY] (see H.R. 7667), H4721 [6MY]

——— set forth limitations on exclusivity for orphan drugs (see S. 4185), S2449 [11MY]

——— strengthen requirements for postapproval studies for drugs approved using accelerated approval (see H.R. 6963), H1329 [7MR]

——— strengthen review and approval of drugs to treat rare diseases and conditions (see S. 4071), S2092 [7AP] (see H.R. 6888), H1207 [1MR]

——— treat certain menstrual products as misbranded if labels do not list each ingredient or component (see H.R. 8829), H7841 [14SE]

Letters

Revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products: Xavier Becerra, Sec. of HHS, S5171, S5172, S5173, S5174, S5175, S5176, S5177 [28SE]

Lists

Votes recorded by proxy on H. Res. 1529, adopt H. Res. 1434, reaffirm FDA preemptive authority relative to State laws that inhibit access to or use of any reproductive health product, H9972 [21DE]

Votes recorded by proxy on H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5403 [8JN]

Notices

Estimated budget effects of H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5330 [7JN]

Remarks in House

Dept. of HHS: improve inspections of foreign drug manufacturing establishments, E594 [8JN]

Diseases and disorders: prohibit vaccination mandates for coronavirus, H343 [2FE]

Drugs: ban use of ingredients or flavor additives in marijuana-infused products, H4030 [31MR]

——— require child-resistant packaging and warning labels detailing dangers posed to pregnant women and unborn babies for marijuana products, H4030 [31MR]

FDA: clarify reporting requirements for establishments within foreign country engaged in manufacture, preparation, propagation, compounding, or processing of active pharmaceutical ingredients, H827 [2FE]

——— improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (H.R. 554), H281 [20JA]

——— improve safety and supply of infant formula, H5344 [8JN]

——— provide for regulation of in-vitro clinical tests, H5320 [7JN]

——— provide for regulation of in-vitro clinical tests (H.R. 4128), H3785 [17MR]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (H. Res. 1434), H9973 [21DE]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (H. Res. 1434), adopt (H. Res. 1529), H9968, H9969 [21DE]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (H.R. 7667), H5298–H5321 [7JN], E594, E599 [8JN], E629 [15JN]

Remarks in Senate

FDA: allow for alternatives to animal testing for purposes of drug and biological product applications (S. 5002), S5514 [29SE]

——— require manufacturers of dietary supplements to list dietary supplements (S. 4090), S2137 [26AP], S4630 [15SE], S7013 [7DE]

——— require prompt reports on marketing status by holders of approved applications for biological products (S. 4302), S2709 [25MY]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, S5171 [28SE]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (H.R. 7667), S4630 [15SE]

Reports filed

Adopt H. Res. 1434, Reaffirm FDA Preemptive Authority Relative to State Laws That Inhibit Access to or Use of Any Reproductive Health Product: Committee on Rules (House) (H. Res. 1529) (H. Rept. 117–660), H9982 [21DE]

FDA Safety and Landmark Advancements (FDASLA) Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 4348), S3269 [13JY]

Revise and Extend FDA User-Fee Programs for Prescription Drugs, Medical Devices, Generic Drugs, and Biosimilar Biological Products: Committee on Energy and Commerce (House) (H.R. 7667) (H. Rept. 117–348), H5331 [7JN]

Statements

FDA User-Fee Programs for Prescription Drugs, Medical Devices, Generic Drugs, and Biosimilar Biological Products Goals and Procedures: Xavier Becerra, Sec. of HHS, S5177–S5220 [28SE]

Tables

Estimated pay-as-you-go effects of H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5330 [7JN]

Texts of

H. Res. 1434, reaffirm FDA preemptive authority relative to State laws that inhibit access to or use of any reproductive health product, H9973 [21DE]

H. Res. 1529, adopt H. Res. 1434, reaffirm FFA preemptive authority relative to State laws that inhibit access to or use of any reproductive health product, H9968 [21DE]

H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5298–H5319 [7JN]

S. 4090, Dietary Supplement Listing Act, S2156 [26AP]

S. 5002, FDA Modernization Act 2.0, S5514 [29SE]